Trial document





This trial has been registered retrospectively.
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  DRKS00000688

Trial Description

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Title

Invasive versus non-invasive methods of blood gas measurement

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

For assessing the patient’s respiratory status pulse oximetry often provides insufficient information. It gives no information about arterial partial pressure of carbon dioxide (PaCO2) and oxygen (PaO2). Blood gas analysis (ABG) is the gold standard for assessing these values. Blood samples can be taken by arterial puncture or from the arterialized earlobe. Both are invasive procedures which can be painful and is occasionally associated with complications.
One major disadvantage of arterial and capillary ABG is that multiple measurements are required when continuous measurement is needed. A device to measure the respirtaory status continuously is transcutaneous analysis of partial pressure of carbon dioxide (PtCO2) and oxygen (PtCO2).
Therefore a sensor heated to 42- 45°C has to be attached to the skin “arterializing” the underlying capillaries. Follwoing blood gases can diffuse through the skin and can be measured by an electrolyte membrane in the sensor and the resulting signal is converted to an estimate of PaCO2 and PaO2.
The aim of this study is to compare arterial and transcutaneous blood gas measurement in special regard to PaO2. Furthermore, capillary ABG from both earlobes will be compared to arterial and transcutaneous ABGs. In additon pain during each intervention will be assessed using a 100 mm visual analogue scale.

Study protocol:
The transcutaneous sensor will be attached using the provided attachment ring and contact gel before arterializing paste is applicated on both earlobes. After stabilization of the transcutaneous measurements ABGs are taken from the radial artery and both earlobes in a randomized order. Samples are analyzed immediately with an arterial blood gas analyzer. Pulse oximetry is performed concomitantly.

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Brief Summary in Scientific Language

For assessing the patient’s respiratory situation pulse oximetry often provides insufficient information. It gives no information about arterial partial pressure of carbon dioxide (PCO2) and oxygen (PO2). Blood gas analysis (ABG) is the gold standard for assessing these values. Blood samples can be taken by arterial puncture or from the arterialized earlobe. Both investigations are invasive procedures which can be painful and is occasionally associated with complications.
In recent studies a suitable agreement between both results could be observed concerning pH and PCO2. In contrast, the agreement of PO2 was partly poor.
Arterial and capillary ABG gives a snap-shot of the respiratory status. If a continuous measurement is required multiple punctures or an arterial line are needed.
A device to measure transcutaneous partial pressure of carbon dioxide (PtCO2) and oxygen (PtCO2) provide a alternative to an ABG in continuous assessment and monitoring of patient’s respiratory situation.
The principle of transcutaneous technique is a diffusion of CO2 and O2 through the skin into a sensor. Therefore the sensor placed to the skin is heated to 42- 45°C to “arterialize” the tissue.
Transcutaneous CO2 devices have been studied in a variety of clinical settings including invasive and non-invasive ventilation in intensive care units and overnight studies of sleep disordered breathing. Limits of agreement and bias have been reported in most studies, with a variety of results depending on the device used and the clinical setting.
Transcutaneous measurement of partial pressure of oxygen hardly has been evaluated yet and it’s accuracy is still discussed controversially. The aim of this study is to compare arterial and transcutaneous blood gas measurement in regard to PO2. Therefore, capillary ABG from both earlobes (BGAkap/r and BGAkap/l) will be compared to arterial and transcutaneous ABGs. In additon pain during each intervention will be assessed using a 100 mm visual analogue scale.
Study protocol:
Measuring probe will be attached using the provided attachment ring and contact gel before arterializing paste is applicated on both earlobes. After stabilization of the transcutaneous measurements ABGs are taken from the radial artery and both earlobes in a randomized order. Samples are analyzed immediately with an arterial blood gas analyzer. Pulse oximetry (SpO2) is performed concomitantly.


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Organizational Data

  •   DRKS00000688
  •   2011/02/23
  •   [---]*
  •   yes
  •   Approved
  •   269/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   respiratory disorder
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Interventions/Observational Groups

  •   transcutaneous measurement of PtcO2 and PtcO2 with probe on thorax
  •   arterial ABG from radial artery
  •   capillary ABG from right earlobe
  •   capillary ABG from right earlobe
  •   Pulsoxymetry
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Other
  •   Crossover
  •   N/A
  •   [---]*
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Primary Outcome

method comparison of transcutaneous PO2 and capillary PaO2 at right ear, each with the goldstandard PaO2

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Secondary Outcome

method comparison Bland und Altmann:
o PartO2 / PtcO2
o Pkap/rO2 / PtcO
o PartO2 / Pkap/rO2
o SpO2 / SaO2 art
o SpO2 / SaO2 kap/r
o SaO2 art / SaO2 kap/r
o PartCO2 / PtcCO2
o Pkap/rCO2 / PtcCO2
o PartCO2 / Pkap/rCO2
o Pkap/rCO2 / Pkap/lCO2
o Pkap/rO2 / Pkap/lO2
o SaO2 kap/r / SaO2 kap/l

ANOVA:
o VAS kap/ VAS art / VAS tc

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/09/08
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

inpatients in the department of pneumology of the university hospital Freiburg receiving arterial or capillary blood gas analysis

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Exclusion Criteria

• patiente < 18 years
• instable patients
• patients peripheral arterial obstructive disease
• patients receiving anticoagulation (e.g. Marcumar)
• patients with coagulopathy(Quick <50%, thrombocytes <50000/µl, PTT >50 sec.)
• patients with blood circulation disorders of the hand

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Freiburg, Abteilung Pneumologie
    • Mr.  Dr.med.  Jan Hendrik  Storre 
    • Kilianstr.5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Abteilung Pneumologie
    • Ms.  Dr.med.  Emelie  Ekkernkamp 
    • Kilianstr.5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Abteilung Pneumologie
    • Ms.  Dr.med.  Emelie  Ekkernkamp 
    • Kilianstr.5
    • 79102  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg, Abteilung Pneumologie
    • Mr.  Dr.med.  Jan Hendrik  Storre 
    • Kilianstr.5
    • 79106  Freiburg
    • Germany
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    • Radiometer GmbH
    • Linsellenstrasse 142
    • 47887  Willich
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/02/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.